2020
Patient-reported outcomes (PROs) in the randomized, phase III IMpower110 study of atezolizumab (atezo) vs chemotherapy in 1L metastatic NSCLC.
de Marinis F, Giaccone G, Herbst R, Oprean C, Szczesna A, Boukovinas I, Bonomi L, Kim Y, Summers Y, Kurata T, Komatsubara K, Chen M, Deng Y, Kuriki H, Mocci S, Phan S, Jassem J, Spigel D. Patient-reported outcomes (PROs) in the randomized, phase III IMpower110 study of atezolizumab (atezo) vs chemotherapy in 1L metastatic NSCLC. Journal Of Clinical Oncology 2020, 38: 9594-9594. DOI: 10.1200/jco.2020.38.15_suppl.9594.Peer-Reviewed Original ResearchPatient-reported outcomesGlobal health statusLung cancer-related symptomsLung cancer symptomsCancer-related symptomsChest painWk 48Metastatic NSCLCSymptom burdenPhysical functionCancer symptomsLife Questionnaire Core 30Carboplatin AUC 6Overall clinical benefitStart of treatmentCompletion ratesAUC 5AUC 6Gemcitabine 1250Meaningful worseningNausea/OS benefitQLQ-LC13Primary endpointPD-L1IMpower110: Clinical safety in a phase III study of atezolizumab (atezo) monotherapy (mono) vs platinum-based chemotherapy (chemo) in first-line non-small cell lung cancer (NSCLC).
Jassem J, Herbst R, de Marinis F, Cadranel J, Csőszi T, Isla D, Chen G, Syrigos K, Cortinovis D, Hida T, Mocci S, Phan S, Enquist I, Patel H, Villalobos M, Wen X, Deng Y, Kuriki H, Spigel D, Giaccone G. IMpower110: Clinical safety in a phase III study of atezolizumab (atezo) monotherapy (mono) vs platinum-based chemotherapy (chemo) in first-line non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2020, 38: e21623-e21623. DOI: 10.1200/jco.2020.38.15_suppl.e21623.Peer-Reviewed Original ResearchNon-small cell lung cancerPD-L1 expressionSafety profileFirst‐line non‐small cell lung cancerCarboplatin AUC 6ECOG PS 0NCI CTCAE v4.0Chemo-naive patientsNew safety signalsPhase III studyPlatinum-based chemotherapyFavorable safety profileCell lung cancerAtezolizumab monotherapyAUC 5AUC 6Gemcitabine 1250Endocrine therapySystemic glucocorticoidsCTCAE v4.0Data cutoffIII studyPS 0PD-L1GEM 1000O81 IMpower110: interim overall survival (OS) analysis of a phase III study of atezolizumab (ATEZO) monotherapy vs platinum-based chemotherapy (CHEMO) as first-line (1L) treatment in PD-L1–selected NSCLC
Herbst R, De Marinis F, Giaccone G, Reinmuth N, Vergnenegre A, Barrios C, Morise M, Font E, Andric Z, Geater S, Ozguroglu M, Mocci S, McCleland M, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, Jassem J, Spigel D. O81 IMpower110: interim overall survival (OS) analysis of a phase III study of atezolizumab (ATEZO) monotherapy vs platinum-based chemotherapy (CHEMO) as first-line (1L) treatment in PD-L1–selected NSCLC. Journal For ImmunoTherapy Of Cancer 2020, 8: a1. DOI: 10.1136/lba2019.1.Peer-Reviewed Original ResearchTreatment-related AEsPD-L1 expressionPrimary endpointArm APD-L1Interim overall survival analysisTumor PD-L1 statusPD-L1/PDCarboplatin AUC 6ECOG PS 0Primary efficacy populationUnexpected safety signalsFirst-line treatmentPD-L1 statusPhase III studyPlatinum-based chemotherapyWT populationOverall survival analysisDeclaration of HelsinkiAttractive treatment choiceAtezolizumab monotherapyAUC 5AUC 6CPI monotherapyECOG PS
2010
Pharmacokinetic study of the phase III, randomized, double-blind, multicenter trial (TRIBUTE) of paclitaxel and carboplatin combined with erlotinib or placebo in patients with advanced Non-small Cell Lung Cancer (NSCLC)
Tran HT, Zinner RG, Blumenschein GR, Oh YW, Papadimitrakopoulou VA, Kim ES, Lu C, Malik M, Lum BL, Herbst RS. Pharmacokinetic study of the phase III, randomized, double-blind, multicenter trial (TRIBUTE) of paclitaxel and carboplatin combined with erlotinib or placebo in patients with advanced Non-small Cell Lung Cancer (NSCLC). Investigational New Drugs 2010, 29: 499-505. PMID: 20094773, DOI: 10.1007/s10637-009-9380-z.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerAdvanced non-small cell lung cancerDrug-drug interactionsErlotinib groupPlacebo groupPotential drug-drug interactionsErlotinib treatment groupPlacebo-treated patientsPossible drug-drug interactionsStandard chemotherapy regimenPhase III trialsCell lung cancerAddition of erlotinibPharmacokinetics of erlotinibMetabolite OSI-420Non-compartmental modelingAUC 6Erlotinib 150Paclitaxel 200Resultant paclitaxelChemotherapy regimenIII trialsUntreated patientsConcomitant administrationMulticenter trial
2009
S0536: Carboplatin, paclitaxel, cetuximab, and bevacizumab followed by cetuximab and bevacizumab maintenance in advanced non-small cell lung cancer (NSCLC): A SWOG phase II study
Gandara D, Kim E, Herbst R, Moon J, Redman M, Dakhil S, Hirsch F, Mack P, Franklin W, Kelly K. S0536: Carboplatin, paclitaxel, cetuximab, and bevacizumab followed by cetuximab and bevacizumab maintenance in advanced non-small cell lung cancer (NSCLC): A SWOG phase II study. Journal Of Clinical Oncology 2009, 27: 8015-8015. DOI: 10.1200/jco.2009.27.15_suppl.8015.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerProgression-free survivalOverall survivalEGFR FISHStable diseasePartial responseNon-squamous cell non-small cell lung cancerDay 1Median age 64 yearsTreatment-related deathsDisease control ratePhase II studyPhase III trialsPlatinum-based chemotherapyAge 64 yearsCell lung cancerEfficacy of carboplatinActive regimenAUC 6Bevacizumab maintenanceEligible ptsMedian followBrain metastasesEfficacy outcomes
2007
Phase II study of bevacizumab in combination with docetaxel and carboplatin in patients with metastatic non-small cell lung cancer (NSCLC)
William W, Kies M, Fossella F, Gladish G, Heymach J, Glisson B, Tse W, Liu D, Herbst R, Lippman S. Phase II study of bevacizumab in combination with docetaxel and carboplatin in patients with metastatic non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2007, 25: 18098-18098. DOI: 10.1200/jco.2007.25.18_suppl.18098.Peer-Reviewed Original ResearchNon-small cell lung cancerMetastatic non-small cell lung cancerCombination of bevacizumabProgression-free survivalSevere adverse eventsStage IIIBPS 0Incurable non-small cell lung cancerChemotherapy-naïve stage IIIBNon-squamous cell histologyMedian age 66 yearsCarboplatin AUC 6Cycles of therapyDisease control rateEfficacy of bevacizumabFull-dose anticoagulationGrade 3 hypertensionHistory of hemoptysisStable cardiac conditionPhase II studyPhase II trialAge 66 yearsFirst-line treatmentCell lung cancerAUC 6
2004
Clinical and pharmacokinetic study of TNP-470, an angiogenesis inhibitor, in combination with paclitaxel and carboplatin in patients with solid tumors
Tran HT, Blumenschein GR, Lu C, Meyers CA, Papadimitrakopoulou V, Fossella FV, Zinner R, Madden T, Smythe LG, Puduvalli VK, Munden R, Truong M, Herbst RS. Clinical and pharmacokinetic study of TNP-470, an angiogenesis inhibitor, in combination with paclitaxel and carboplatin in patients with solid tumors. Cancer Chemotherapy And Pharmacology 2004, 54: 308-314. PMID: 15184994, DOI: 10.1007/s00280-004-0816-z.Peer-Reviewed Original ResearchConceptsPharmacokinetics of carboplatinTNP-470Solid tumorsDoublet regimenAngiogenesis inhibitor TNP-470Hematological toxic effectsRegimen of paclitaxelCycles of therapyMedian survival durationCombination of paclitaxelPatient survival ratesRecent clinical trialsHead/neckCell lung carcinomaTNP-470 administrationToxic effectsAUC 5AUC 6Chemotherapy doubletsIntravenous paclitaxelPurposePreclinical studiesStable diseasePartial responseRandomized studySurvival duration